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. 2019 Oct 22;2019(10):CD005015. doi: 10.1002/14651858.CD005015.pub4

Grotz 2001.

Methods
  • Study design: parallel RCT

  • Duration of study: not reported

  • Duration of follow‐up: 12 months

Participants
  • Country: Germany

  • Setting: single centre

  • Inclusion criteria: patients aged 20 to 60 years awaiting transplantation

  • Number: treatment group (36); control group (36)

  • Mean age ± SD (years): treatment group (42 ± 10); control group (44 ± 10)

  • Sex (M/F): treatment group (25/11); control group (23/13)

  • Diabetes: treatment group (1/36); control group (1/36)

  • Exclusion criteria: combined kidney‐pancreas transplantation

Interventions Treatment group
  • Ibandronate: 1 mg immediately before transplantation and 2 mg at 3, 6, and 9 months


Control group
  • No treatment


Co‐interventions
  • Not reported

Outcomes
  • Biochemical parameters (calcium, phosphate, creatinine)

  • BMD of femoral neck, lumbar spine and forearm by DEXA

Notes
  • Funding source: not reported

  • Trial registration: not applicable as published before end of 2005

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Unblinded study
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk All X‐rays were evaluated by a radiologist who was blinded to the randomisation
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 8/80 patients did not complete the study with equal numbers in each group
Selective reporting (reporting bias) Low risk Patient‐centred outcomes including graft function were reported
Other bias Low risk No additional threats to validity identified